MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48480111
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tip of rod inserter came loose during rod insertion.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were found upon manufacturing history review.Upon dhr review, instrument was found to be almost 5 years old.Per email correspondence with the sales rep, the instrument has been used hundreds of times.The possible root cause of this event is normal wear and tear of the instruments.
Event or Problem Description
It was reported that's tip of rod inserter came loose during rod insertion.

• Brand Name: MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5740188
• Report Number: 0009617544-2016-00243
• Device Sequence Number: 10763917
• Product Code: LXH
• UDI-Device Identifier: 07613327270815
• UDI-Public: (01)07613327270815
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48480111
• Device Lot Number: 119235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1